Vscan UM GM092102 5 00 PDF

GE Healthcare
Technical Publications
Vscan
Version 1.x.x
User Manual
GM092102 — English
Rev. 05
Operating Documentation
Copyright © 2010 and 2011 By General Electric Co.
Regulatory requirement
This product complies with regulatory requirements of the following European

Directive 93/42/EEC concerning medical devices.
This manual is a reference for the Vscan. It applies to all versions of the 1.x.x
software for the Vscan ultrasound system.
This manual is a reference for the Vscan gateway software. It applies to all
versions of the 1.x.x Vscan gateway software.
GE Healthcare
Manual status:
GM092102-05
19 January 2011
Manufacturer:
GE VINGMED ULTRASOUND AS
Strandpromenaden 45
N-3191 Horten, Norway
Tel.: (+47) 3302 1100 Fax: (+47) 3302 1350
Regulatory Requirements
Conformance Standards
The GE Healthcare product families are tested to meet all
applicable requirements in relevant EU Directives and
European/International standards. Any changes to accessories,
peripheral units or any other part of the system must be
approved by the manufacturer: GE Vingmed Ultrasound.
Ignoring this advice may compromise the regulatory approvals
obtained for the product.
This product complies with the regulatory requirement of the
following:
Standard/Directive Scope
93/42/EEC Medical Devices Directive (MDD)
EN55011 Emitted noise according to Class B requirements
IEC60601-1 Medical Electrical Equipment, Part 1; General Requirements

EN60601-1 for Safety
UL60601-1
CAN/CSA-C22.2 No 601.1-M90
IEC60601-2-37 Medical electrical equipment - Part 2-37. Particular

requirements for the safety of ultrasonic medical diagnostic
and monitoring equipment
IEC1157 / EN61157 Requirements for the declaration of the acoustic output of

medical diagnostic ultrasonic equipment.
IEC60601-1-2 Medical Electrical Equipment - part 1-2. Collateral standard:

EN60601-1-2 Electromagnetic compatibility - Requirements and tests.

EN60601-1-4 Programmable electrical medical systems

Usability.
NEMA/AIUM UD-3 Standard for real-time display of thermal and mechanical

acoustic output indices on diagnostic ultrasound equipment.
ISO10993-1 Biological evaluation of medical devices
Vscan – User Manual i-1

GM092102 05
Country Specific Approvals
• JAPAN
MHLW Approved Number: 221ABBZX00252000
• CHINA
SFDA:
Product Standard Number:
• KOREA
KFDA:
Certifications
• GE Vingmed Ultrasound is ISO 9001 and ISO 13485
certified.
Classifications
The following classifications are in accordance with the IEC/
EN 60601-1.
Type and degree of protection against electric shock:
• Vscan is internally powered battery operated during hand
held scanning.
• The AC adapter is Class II.
• Vscan has type BF Applied Part.
• Degree of protection against harmful ingress of water:
Vscan parts and accessories except probe tip: ordinary
equipment (IPx0)
Probe tip: IPX1
Class II Equipment
EQUIPMENT in which protection against electric shock does not
rely on BASIC INSULATION only, but in which additional safety
precautions such as DOUBLE INSULATION or REINFORCED
INSULATION are provided, there being no provision for
protective earthing or reliance upon installation conditions.
i-2 Vscan – User Manual

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Type BF Applied part
TYPE BF APPLIED PART providing a specified degree of
protection against electric shock, with particular regard to
allowable LEAKAGE CURRENT.
Normal mode Single fault condition
Patient leakage current <100 microA <500 microA
Environmental requirements for the unit
Humidity
Requirement Temperature non-condensing Air Pressure
Operational 10–40 °C 30–80% 700–1060 hPa
Non operational -20–70 °C 30–90% 700–1060 hPa
NOTE: Avoid exposing the unit to saline moisture. In case of exposure

to saline moisture, clean the unit as described on page 6-4.
Original Documentation
• The original document was written in English.

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GM092102 05
Table of Contents
Conformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-1

Country Specific Approvals - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-2
Certifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-2
Classifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-2
Class II Equipment - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-2
Type BF Applied part - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3
Environmental requirements for the unit - - - - - - - - - - - - - - - - - - - - - - - - i-3
Original Documentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3
Table of Contents
Chapter 1 — Introduction
General description
Principles of operation- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2
Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2
Indication for use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3
Contraindication - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3
Warnings
Conventions used in this manual
Contact Information
Contacting GE Healthcare Ultrasound - - - - - - - - - - - - - - - - - - - - - - - - 1-7
Global ultrasound support center phone numbers - - - - - - - - - - - - - - - - 1-8
Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-11
Chapter 2 — Preparing the Vscan for use
Package contents
System description
System overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5
Battery
Power plug adapter- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-12
Charging the battery using the Docking station - - - - - - - - - - - - - - - - - 2-12
Charging the battery using the External battery charging compartment 2-13
Battery level indicator - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-14
Removing / inserting the battery (GM-BAT) - - - - - - - - - - - - - - - - - - - - 2-15
Battery (GM-BAT) specifications - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-16
The microSD card
Removing / inserting the microSD card - - - - - - - - - - - - - - - - - - - - - - - 2-17
The microSD card memory indicator- - - - - - - - - - - - - - - - - - - - - - - - - 2-19
The microSD card handling recommendations- - - - - - - - - - - - - - - - - - 2-20
First time use
Installing the battery - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-21

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Vscan activation
Vscan activation procedure - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-22
Chapter 3 — Using Vscan
Switching on/off
To switch on the Vscan - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2
To switch off the Vscan - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2
Scanning
General scanning recommendations- - - - - - - - - - - - - - - - - - - - - - - - - - 3-3
Probe orientation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-5
Patient examination - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-5
Presets - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-6
Black and white imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-6
Color imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-7
Auto freeze - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-8
AutoCycle - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-8
Measurements
Taking measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-9
Voice notations
Recording Voice notations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-10
Review and storage
Reviewing acquired images - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-11
Storage of images- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-11
Recall of stored data
Deletion of data
To delete an examination - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-14
To delete a file - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-14
Chapter 4 — Vscan gateway software
Overview
About the files created in Vscan - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2
Vscan gateway software installation
Computer requirements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-4
Installation and activation of Vscan gateway software - - - - - - - - - - - - - 4-5
Connection of Vscan to a computer
Using Vscan gateway software
Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-14
Gallery screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-15
Setup screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-20
Chapter 5 — Vscan configuration
Config menu
System setup adjustment - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-3
Chapter 6 — Vscan maintenance
System care and maintenance
Inspection
Inspecting the Vscan- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-3
Inspecting the probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-3

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Cleaning and disinfection
Cleaning - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-4
Disinfection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-5
Reinstallation of the factory software
Procedure - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-7
Troubleshooting
Vscan troubleshooting- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-9
Vscan gateway software troubleshooting - - - - - - - - - - - - - - - - - - - - - 6-10
Chapter 7 — Safety
Introduction
Owner responsibility
Notice against user modification- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-3
Important safety considerations
Patient safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-5
Personnel and equipment safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-7
Electromagnetic Compatibility (EMC) - - - - - - - - - - - - - - - - - - - - - - - - - 7-9
Acoustic output- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-16
Environmental protection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-18
Probe overview
Maximum probe temperature
Device labels and symbols
Chapter 8 — Appendix
Acoustic Output Reporting Tables
Definitions, symbols and abbreviations - - - - - - - - - - - - - - - - - - - - - - - - 8-2
Acoustic Output Reporting Tables for Track 3/IEC 60601-2-37 - - - - - - - 8-5
Measurement accuracy
Distance measurement - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-7
Area measurement - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-7
Medical Ultrasound Safety
Medical Ultrasound Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-9
Index

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Chapter 1
Introduction
Contents:
‘General description’ on page 1-2
‘Warnings’ on page 1-4
‘Conventions used in this manual’ on page 1-6
‘Contact Information’ on page 1-7
Vscan – User Manual 1-1

GM092102 05
Introduction
General description
Vscan is a battery operated pocket-sized general purpose

ultrasound imaging system.
Principles of operation
Medical ultrasound images are created by computer and digital
memory from the transmission and reception of mechanical
high-frequency waves applied through a probe. The mechanical
ultrasound waves spread through the body, producing an echo
where density changes occur. The echoes return to the probe
where they are converted back into electrical signals.
These echo signals are amplified and processed by several
analog and digital circuits having filters with many frequency and
time response options, transforming the high-frequency
electrical signals into a series of digital image signals which are
stored in memory. Once in memory, the image can be displayed
in real-time on the image monitor.
A probe is an accurate, solid-state device, providing multiple
image formats. The digital design and use of solid-state
components provides highly stable and consistent imaging
performance with minimal required maintenance. Sophisticated
design with computer control offers a system with extensive
features and functions which is user-friendly and easy to use.
Safety
Read and understand all instructions in the User's Manual
before attempting to use the ultrasound unit. Keep the manual
with the equipment at all time. Periodically review the
procedures for operation and safety precautions.
All information in Chapter ‘Safety’ on page 7-1 should be
read and understood before operating the ultrasound unit.
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General description
Indication for use

The Vscan ultrasound unit is intended for the following
applications:
• Cardiac adult and pediatric
• Abdominal
• Pediatric
• Urology
• Fetal
• Peripheral vascular
• Thoracic/Pleural motion and fluid detection
Contraindication
The Vscan ultrasound unit is not intended for ophthalmic use or
any use causing the acoustic beam to pass through the eye.
CAUTION For USA only:

United States law restricts this device to sale or use by, or on
the order of a physician.

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Introduction
Warnings
To prevent damage of the equipment or injury to yourself or

others, read the following safety warnings before using the
Vscan.
WARNING • Vscan is a precision instrument. Handle Vscan and its

accessories with care. Do not subject Vscan to mechanical
shock or impact.
• Do not attempt to disassemble or alter any part of the unit
including the probe, the battery, the AC/DC adapter and
accessories. Disassembly or modification may result in
electrical shock.
• Stop using the unit if it emits smoke or noxious fumes.
Failure to do so may result in electrical shock or fire.
• Stop using the unit if the casing is damaged, including the
probe. Failure to do so may result in electrical shock.
• Do not use the AC/DC adapter if showing visible damages.
• Use only the designated power accessories (battery and
charger). Failure to do so may result in electrical shock or
fire.
• Do not place the battery near a heat source or expose it to
direct flame. Such exposure may lead to corrosive liquid
leakage, electrical shock or fire.
• If any liquid from battery should come in contact with the
eye, immediately wash the eye with plenty of water and
seek medical advice as soon as possible.
• Do not immerse or expose the battery to water.
• To reduce risk for electrical shock, do not plug or unplug
the AC/DC adapter from mains socket with wet hands.
• Avoid dropping or subjecting the unit, including the probe,
the battery and accessories to severe impacts. This could
result in electrical shock, corrosive liquid leakage and
injury.

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Warnings
WARNING • Do not short-circuit the battery terminal with metallic

objects. This may result in overheating and burns.
• Do not store or carry a battery loosely with metallic
devices.
• Disconnect the battery charger when not in use to avoid
fire hazard.
• Keep the charger dry. Failure to observe this precaution
may result in fire and electric shock
• Keep this unit out of reach of children.

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Introduction
Conventions used in this manual
Buttons and other controls on the Control panel or on the

monitor screen are indicated by bold type.
Program windows, screens and Dialogue boxes are indicated by
italic type.
The following icons, highlight safety issues as follow:
DANGER Indicates that a specific hazard exists that, given inappropriate

conditions or actions, will cause severe or fatal personal injury
with or without substantial property damage.
WARNING Indicates that a specific hazard exists that, given inappropriate

conditions or actions, can cause severe or fatal personal injury
with or without substantial property damage.
CAUTION Indicates that a potential hazard may exist that, given

inappropriate conditions or actions, can cause minor injury or
property damage.

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Contact Information
Contact Information
Contacting GE Healthcare Ultrasound

For additional information or assistance, please contact your
local distributor or the appropriate support resource listed on the
following pages:
Internet
https://vscan.gehealthcare.com
http://www.gehealthcare.com
USA
GE Healthcare TEL: (1) 800-437-1171

Ultrasound Service Engineering FAX: (1) 414-721-3865
9900 Innovation Drive
Wauwatosa, WI 53226
Clinical Questions
Please contact your local Applications or Sales Representative.
Service Questions
For service in the United States, call GE CARES

TEL: (1) 800-437-1171
NOTE: When contacting GE CARES you will have to provide your
system ID. If system ID is unknown, please give the Temporary
System ID “VSCAN” to be properly routed for support.
In other locations, contact your local Service Representative.

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Introduction
Accessories Catalog Requests
To request the latest GE Accessories catalog or equipment

brochures in the United States, call the Response Center
TEL: (1) 800-643-6439
In other locations, contact your local Applications, Sales or
Service Representative.
Placing an order
To place an order, order supplies or ask an accessory-related

question in the United States, call the GE Access Center
TEL: (1) 800-472-3666
In other locations, contact your local Applications, Sales or
Service Representative.
Global ultrasound support center phone numbers

For countries not listed in the tables below, please contact the
local distributor.
Americas
Region Telephone Location
United States1 800-437-1171 Milwaukee
Canada 800-668-0732 Moncton
Mexico 0800 9043400 Sao Paulo
Puerto Rico 0800 4371171 Sao Paulo
Brazil 0800 122345 Sao Paulo
Argentina 0800 3331984 Sao Paulo
Chile 0800 367000 Sao Paulo
1
For USA only: when contacting GE CARES you will have to provide your system ID. If system ID is
unknown, please give the Temporary System ID “VSCAN” to be properly routed for support.

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Contact Information
Europe, Middle East and Africa
Algeria +21321484612
Andorra 902 400 246
Austria 0800244260 Vienna
Belgium Dutch +32 262 638 38 Diegem
Belgium French +32 262 638 39 Diegem
Bulgarian +35929712040 Sofia
Denmark 80404944 Stockholm
Egypt +202 19434 [hot line] Cairo
Finland 0981710182 Stockholm
France 0800139140 Velizy
G. D. Luxembourg 080022973 Diegem
Germany 08004373784 Solingen
Greece 302109690660 Athens
Holy See 800 827168 Milan
Hungary +36-23-410-510 Budapest
Ireland 1800992557 Dublin
Israel Contact local distributor Tel Aviv
Italy Central 800 827168 Milan
Italy North-East 800 827166 Milan
Italy North-West 800 827164 Milan
Italy South 800 827170 Milan
Liechtenstein 0041 44 809 9293
Monaco 0800139140
Netherlands 8000994442 Diegem
Northern Ireland 08000720248 Belfast
Norway 80062043 Stockholm
Portugal 800 834 004 Madrid
Russia +7 495 739 69 75 Moscow
San Marino 800 827168 Milan
Saudi Arabia 800 1243002 Saudi Arabia

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Introduction
South Africa 800 111 671 South Africa
Spain 902 400 246 Madrid
Sweden 0201201436 Stockholm
Switzerland 0800556958 Zurich
Turkey Contact local distributor Istanbul
UAE 800 3646 Saudi Arabia
UK 0845 8503392 Bedford
Ukraine +38 044 391 37 56 (57)

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Contact Information
Asia and Pacific
China 8008108188 Beijing
Hong Kong (852) 21006288 Hong Kong
Taiwan 0800-021-770 Taipei
India (91) 1800-425-8025 Bangalore
Singapore (65) 62773444 Singapore
Australia 1-800-659-465 Brisbane
New Zealand 0800 65 94 65 Brisbane
Japan 0120-055-919 Tokyo
Korea (82) 2-1544-6119 Seoul
Bangladesh (880) 29135488 Dhaka
Sri Lanka (94) 114891178 Colombo
Bhutan Contact GE India
Maldives Contact GE India
Nepal Contact local distributor
Malaysia 1800 88 3911 Kuala Lumpur
Thailand (66) 26248400 Bangkok
Vietnam Contact local distributor
Philippines Contact local distributor
Indonesia Contact local distributor
Laos Contact local distributor
Brunei Darussalam Contact local distributor
Cambodia Contact local distributor
Manufacturer
GE VINGMED ULTRASOUND AS
Strandpromenaden 45
N-3191 Horten, Norway
Tel.: (+47) 3302 1100 Fax: (+47) 3302 1350

GM092102 05
Introduction

GM092102 05
Chapter 2
Preparing the Vscan for use
Contents:
‘Package contents’ on page 2-2
‘System description’ on page 2-5
‘Battery’ on page 2-11
‘The microSD card’ on page 2-17
‘First time use’ on page 2-21

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Package contents
Make sure all items listed below are included in the package.
1. Vscan unit
Storage microSD card installed in Vscan
2. Soft bag
3. USB 2.0 cable
4. Battery (GM-BAT)
5. Coupling gel
6. SD card adapter

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Package contents
1. Quick card
2. CD-ROM Vscan gateway software
3. CD-ROM user manual
4. microSD card with factory SW (In a sealed envelope – only to be used in agreement with service
organization)

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1. Docking station
2. AC/DC converter
3. Adapter plugs

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System description
System description
System overview
The Vscan device
1. Probe G3S 5. Microphone

2. Control panel 6. Docking station connector
3. Display 7. Battery (GM-BAT) and microSD card
4. Loud speaker compartment lid
Figure 2-1. The Vscan device

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The display
Black and white scanning screen (default) Menu screen (displayed when pressing Menu.)
1. Scanning information 1. Menu items
• Examination number (page 3-5) • New Exam: create new examination
• Current date (page 3-5).
• Current time • Distance: make a measurement (page 3-9).
• Scanning preset (page 3-6) • Presets: select an acquisition preset
• Mechanical and Thermal Index (page 7-16) (page 3-6).
2. Depth scale (page 3-7) • Gallery: review stored examinations
3. Orientation marker (page 3-5) (page 3-11).
4. Header • Config: configure the Vscan (page 5-1).
• Battery level indicator (page 2-14)
• Memory indicator of the microSD card
(page 2-19)
Figure 2-2. Screens

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System description
The Control panel
Key Usage
Select key
• Freeze/unfreeze in live mode.
• In a menu or a dialog: select highlighted item.
• Press and hold to return to black and white imaging.
• Navigate in menus.
• Navigate through examinations in the Gallery screen.
• Move color area and caliper.
• Navigate in menus.
• Pause/play movie.
• Navigate through examinations in the Gallery screen.
• Decrease Depth.
• Navigate through files in Gallery screen.
• Increase Depth.
• Navigate through files in Gallery screen.
Rotate function
• Scroll in menus.
• Adjust Gain.
• Scroll in a movie when in pause.
Color imaging key

• Enter/exit color imaging.

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Key Usage
Store key
• Store current acquisition (movie or single frame).
• Press and hold to start voice notation. Press any key to end voice notation.
Menu key
• Enter the system menu.
• Move one level up in system menu.
• Exit the system menu.

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System description
The Docking station
The Docking station is used to:

• Connect the Vscan to a computer.
• Charge the Vscan battery.
• Store the Vscan when not in use.
NOTE: The Docking station is designed for in-house use only. Do not
use the Docking station in ambulance or other vehicles.
1. Vscan cradle 4. Charger (GM-CHA) connector

2. Probe holder 5. USB port to computer
3. Vscan connector
Figure 2-3. Docking station

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The External battery charging compartment (option)
The external battery charging compartment is used to charge

spare battery outside the Vscan.
1. Charger (GM-CHA) connector
Figure 2-4. External battery charging compartment

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Battery
Battery
The Vscan is powered by a Lithium Polymer battery (GM-BAT).

The battery is not fully charged at shipment. To maximize time of
use, it is recommended to recharge the battery before use for at
least 1.5 hour. Make sure to establish a routine for charging the
battery to maximize system availability.
It is recommended to charge the battery (GM-BAT) in the Vscan
placed on the Docking station, or by using the external battery
charging compartment as described below.
Use only the AC adapter provided with the Vscan.
1. Charger (GM-CHA)
2. AC/DC adapter
Figure 2-5. The Vscan AC adapter
CAUTION The AC adapter, the Docking station and the external battery
charging compartment must be kept outside the patient
environment (refer to local regulation and EN 60601-1).
1. Patient environment
Figure 2-6. Patient environment

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CAUTION Do NOT touch simultaneously the patient and the charger plug
on either the AC/DC adapter, the Docking station or the
external battery charger.
Power plug adapter

1. Select the country specific plug.
1. North America, Japan

2. China
3. Australia New Zealand
4. UK, Hong Kong, Singapore
5. Continental Europe and Korea (for unearthed electrical outlet)
6. Continental Europe and Korea (for earthed electrical outlet)
2. Place the plug onto the AC/DC adapter.

3. Press the button and turn the plug clockwise until it locks in
place.
Charging the battery using the Docking station

1. Place the Vscan on the Docking station.

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Battery
2. Plug the charger (GM-CHA) plug into the charger connector

on the Docking station.
3. Plug the AC/DC adapter into the electrical outlet.
CAUTION Only use mains power of 100 – 240 VAC. Voltage outside
this range can cause malfunction or destroy the AC/DC
adapter.
The charge lamp on the charger (GM-CHA) is lit in amber

when charging the battery and turns green when the battery
is fully charged.
Charging the battery using the External battery charging

compartment
1. Insert the battery (GM-BAT) in the compartment until the lid
clicks in place.
2. Plug the charger (GM-CHA) plug into the charger connector
on the external battery charging compartment.
3. Plug the AC/DC adapter into the electrical outlet.
CAUTION Only use mains power of 100 – 240 VAC. Voltage outside
this range can cause malfunction or destroy the AC/DC
adapter.
The charge lamp on the charger (GM-CHA) is lit in amber

when charging the battery and turns green when the battery
is fully charged.

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Battery level indicator

The battery level indicator is displayed on the header. The
following icons are displayed.
Icon Description
Battery fully charged.
Battery partially discharged.
Low Battery, prepare to recharge the battery or have a spare

battery available.
Discharged battery, recharge the battery or replace with a

spare battery.
Battery charging.

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Battery
Removing / inserting the battery (GM-BAT)
To remove the battery
1. Close the display.
CAUTION Do not attempt to remove the battery without closing the

display.
2. Push the button on the battery compartment lid and pull the
battery (GM-BAT) out.
To insert the battery

clicks in place.

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Battery (GM-BAT) specifications
Item Specification
Charging time about 1.5 hour
Capacity about 1 hour active use
Lifetime At least 300 charges
In order to get maximum charging capacity with your Vscan

battery (GM-BAT), you should allow the battery to be fully
charged and then fully discharged at least three times. The unit
can be used as normal during these cycles. Once these initial
charging/discharging cycles are performed, the following is
applicable without reducing the life time of the battery:
• It is not necessary to completely discharge the battery
before re-charging it.
• It is possible to stop charging the battery before it is fully
charged, but the battery will then be discharged more
rapidly.
• It is possible to charge the battery several times each day, if
needed.

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The microSD card
The microSD card
Image acquisitions and voice notation recordings are stored to a

microSD card (MicroSD or MicroSDHC, speed grade 6 or
lower).
The microSD card is located under the battery.
Removing / inserting the microSD card
To remove the microSD card
1. Remove the battery (GM-BAT) (see page 2-15).

2. Slide and raise the card slot.
3. Remove the microSD card from the card slot.

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4. Lower and slide the slot card back in place.
To insert the microSD card
1. Remove the battery (GM-BAT) (see page 2-15).

2. Slide and raise the card slot.
3. Insert the microSD card in the card slot.

Orientation

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The microSD card
Make sure the card is inserted in the card slot.
4. Lower and slide the slot card back in place.
5. Insert the battery (GM-BAT) in the compartment (see

page 2-15).
The microSD card memory indicator

The microSD card memory indicator is displayed on the header.
The following icons are displayed.
Icon Description
The card is empty
The card is partially filled up
The card is nearly full
The card is full
No card in the Vscan device, or card disabled from device while

mounted to computer.

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The microSD card handling recommendations

The microSD cards are sensitive electronic devices.
• Do not bend the microSD cards or subject them to shocks or
vibrations.

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First time use
First time use
Before the Vscan can be used the following steps must be done:
• Install and charge the battery.
• Activate the Vscan (page 2-22).
Installing the battery

clicks in place.
2. Make sure the battery is fully charged (see page 2-11)

before activating the Vscan.

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Vscan activation
The Vscan must be activated before it can be used. The

activation consists of entering a specific activation key that is
generated after providing the Vscan’s serial number and owner
information to the Vscan web portal.
NOTE: If you do not have access to the Internet, the activation can be
done by contacting the GE hotline center (see ‘Global
ultrasound support center phone numbers’ on page 1-8).
Vscan activation procedure

1. Open your Internet browser and visit the Vscan web portal
(http://vscan.gehealthcare.com).
2. Select Login if you already are registered to the site or
Register if you are a new user.
3. Follow the directions provided in the site to generate the
activation key for the Vscan.
The following information is required:
• The Vscan serial number written on the rear label of the
control unit.
• Some user information.
4. Open the display to start the Vscan.
After initialization the Vscan Setup wizard is started
displaying the Language screen.
Language selection
1. Press Select to display the list of available languages.

Use / to browse through the available languages until
the desired language is highlighted.

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Vscan activation
2. Press Select when done.

3. Press to continue the configuration.
The Activation key screen is displayed.
Activation key
1. Use / / / to highlight the digit or character to

enter and press Select.
The next entry in the activation key is highlighted.

2. Repeat step 1 until all 25 entries in the activation key are
filled in.
NOTE: Select or on the keyboard to navigate through the
activation key entries if changes need to be done.
A message is displayed on screen to confirm that the key is
accepted.
The Adjust time screen is displayed.

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Adjust time
1. Use / to navigate between hours, minutes and

seconds.
Use / (or Rotate) and press Select to set each item.

The Date screen is displayed.
Adjust date
1. Use / to navigate between days, months and years.

Use / (or Rotate) and press Select to set each item.
2. Press to end the configuration.

The Vscan is ready for use.

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Chapter 3
Using Vscan
Contents:
‘Scanning’ on page 3-3
‘Measurements’ on page 3-9
‘Voice notations’ on page 3-10
‘Review and storage’ on page 3-11
‘Recall of stored data’ on page 3-13
‘Deletion of data’ on page 3-14

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Using Vscan
Switching on/off
To switch on the Vscan

1. Open the display.
After initialization the black and white scanning screen is
displayed.
To switch off the Vscan

There are two ways to switch off the Vscan:
• Close the display
Or
• Use the Shutdown menu
NOTE: The system will delete any acquisition that is not stored when
closing the display. To save the current acquisition, press Store
before closing the display.
Switch off using the Shutdown menu
1. Press Menu.
2. In the main menu, Rotate (or use / ) to browse
through the menu items and highlight Config .
3. Rotate (or use / ) to browse through the menu items
and highlight Shutdown .
4. Press Select.

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Scanning
Scanning
General scanning recommendations
Before each use:
• Inspect the probe (see ‘Inspecting the probe’ on page 6-3).
After each use:
• Inspect the probe (see ‘Inspecting the probe’ on page 6-3)

• Clean the probe (see ‘Disinfection’ on page 6-5).
• If required disinfect the probe (see ‘Disinfection’ on
page 6-5).
CAUTION If any damage is found on the probe or its cable, DO NOT use
the Vscan. Contact GE service.
Use of gel
In order to assure optimal transmission of energy between the

patient and the probe, a conductive gel must be applied on the
probe lens.
CAUTION Do not apply gel to the eyes. If there is gel contact to the eye,
flush eye thoroughly with water.

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Using Vscan
Coupling gels should not contain the following ingredients as

they are known to cause probe damage:
• Methanol, ethanol, isopropanol, or any other alcohol-based
product
• Mineral oil
• Iodine
• Lotions
• Lanoline
• Aloe Vera
• Olive Oil
• Methyl or Ethyl Parabens (para hydroxybenzoic acid)
• Dimethylsilicone
The following gels have been tested to be compatible with the
Vscan.
Aquasonics 100 Parker Laboratory Inc.
Clear Image Sonotech Inc.
Scan Parker Laboratory Inc.
Sonogel Sonogel Vertriebs
Other recommendations
Like most high frequency computing devices, the electronic

components of Vscan will generate some heat while operating
normally and as intended. Vscan is equipped with safety
mechanisms which will automatically reduce computing speed
(frame rate), and ultimately shut down the device, before any
risk of overheating occurs. Vscan is verified to comply with
harmonized safety standards (see ‘Conformance Standards’ on
page i-1), under any operating condition described in this user
manual (see Environmental properties on page i-3). To help
keeping the Vscan operating temperature at an optimal
functional level, and to ensure longer scanning time with
maximum frame rate, it is recommended to hold the Vscan so
that there is good contact between the device and the hand.
Image display on Vscan is dependent of the ambient light, avoid
direct sun light on the display when scanning and reviewing
images.

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Scanning
CAUTION Do not scan on open wound.
Probe orientation
The probe is provided with an orientation marking. This mark is
used to identify the end of the probe corresponding to the side of
the image having the orientation V mark on the scanning screen.
1. Orientation marking on probe

2. Orientation marking on screen
Patient examination
When scanning several patients make sure to create a new
examination between each patient. To create a new
examination:
1. Press Menu.
and highlight New exam .
3. Press Select.
A new examination is created. The examination number is
displayed on the screen.

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Using Vscan
NOTE: A new examination is also created automatically when the

system is restarted.
Presets
To ensure optimal image quality the Vscan has predefined
scanning settings optimized for different applications (e.g
Cardiac, Abdominal). Make sure to select the correct preset
before scanning.
The current preset is displayed on the screen.
To change preset:
1. Press Menu.
and highlight Presets .
3. Press Select.
The Preset menu is displayed.
4. Browse to the desired preset and press Select.
Icon Preset Optimized for
Cardiac Heart
Aorta
Thoracic/Pleural motion and fluid detection
Abdominal Liver
Kidney
Gall bladder
Spleen
Urology
Peripheral vascular
Obstetrics OB/Gyn
Black and white imaging

Black and white imaging is intended to provide two-dimensional
images and measurement capabilities concerning the
anatomical structure of soft tissue.
Black and white is the default scanning mode.
NOTE: As a safety precaution, scanning is not possible when charging
the battery and when connected to a computer.
1. Start scanning.

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Scanning
2. The following adjustments can be done to further improve

the image quality:
• Auto optimize: press and hold down Select. A green
dot is displayed on the left of the image sector indicating
that the image settings have been optimized based on
the current acquisition.
To turn off Auto optimize, press and hold down Select.
NOTE: If you change the probe position or adjust the Depth you
may need to optimize again.
• Depth /
Depth adjusts the field of view. It increases the field of
view to look at larger or deeper structures; it decreases
the field of view to look at structures near the skin line.
NOTE: The depth setting is indicated on a depth scale.
• Gain (Rotate)
Black and white gain increases or decreases the
amount of echo information displayed in an image. It
may have the effect of brightening or darkening the
image if sufficient echo information is generated.
Color imaging
Color imaging is a Doppler Mode intended to add color coded
qualitative information concerning the relative velocity and
direction of fluid motion within the black and white image.
1. Press Color .
A color area is displayed on top of the black and white
image.
2. Use / / / to move the color area over the
region of interest.
3. The following adjustment can be done to further improve the
image quality:
• Color gain (Rotate)
Color gain amplifies the overall strength of echoes
processed in the color area. It allows control of the
amount of color within a cavity.
NOTE: Press Color to toggle color display on/off.

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Using Vscan
Color aliasing
If the blood flow velocity exceeds the maximum velocity range

the system can cover, based on the sampling rate used, aliasing
will occur.
Aliasing will appear as a shift in color from the color representing
positive velocity to color representing negative velocity or visa
versa.
The maximum velocity is displayed on top of the color bar.
Auto freeze
If Vscan is idle for more than the Auto freeze time set in Config it
enters in freeze mode to minimize overheating. Press Select to
start scanning again.
AutoCycle
Vscan does not include an ECG interface as often found on
larger ultrasound systems intended for cardiovascular
applications. The AutoCycle feature detects a complete cardiac
cycle by analyzing the cyclicity of the ultrasound intensity data.
The resulting time-stamps are used for storing and playing
cineloops smoothly. The AutoCycle feature should typically
detect heart rates in the range 46–100 beats per minute. If the
detected heart cycle is outside this range, or if the cyclicity
quality is too poor, a default 2 sec loop will be used instead. The
detected start and stop times for the AutoCycle are not
necessarily in phase with the QRS complex. Since adequate
cyclicity can only be expected in cardiac applications, all other
applications will use the default 2 sec loop.

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Measurements
Measurements
Taking measurements
The Vscan enables distance measurement on frozen images in
both black and white and color imaging. Up to three
measurements can be performed on an image. Measurements
can be done during image review before storage or on recalled
stored images.
To perform a measurement:
1. On a frozen image, press Menu.
through the menu items and highlight Distance .
3. Press Select.
A red caliper is displayed.
4. Use / / / to move the caliper to the start point
of the measurement.
5. Press Select to anchor the start point.
A new green caliper is displayed.
6. Use / / / to move the caliper to the end point
of the measurement.
7. Press Select to anchor the end point.
The performed measurement is displayed with the
measured value next to the end point.
8. To store the image with measurement, press Store .

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Using Vscan
Voice notations
Recording Voice notations

Voice notations can be recorded at any time. The voice
notations are stored in the current examination folder.
To make a voice notation:
1. Press and hold down Store to start recording.
2. Record your message.
A red blinking recording symbol and a timer are displayed
while recording.
3. Press any button to end recording.
The voice notation is saved to the current examination
folder.

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Review and storage
Review and storage
During live scanning, acquired images are temporarily stored on

the system’s memory (image buffer). When the system’s
memory is full, new images are replacing the oldest acquisitions.
To keep images the acquisition has to be stored to the microSD
card.
Reviewing acquired images

1. While scanning, press Select to freeze the image.
2. While in freeze, Rotate to scroll through the acquired
images one by one.
3. Press to display the acquisition as a movie.
NOTE: Press to play/pause the movie. To start scanning again,
press Select.
Storage of images
Images and voice notations for the current examination are
stored to the microSD card on a dedicated examination folder.
Each time the system is restarted a new examination is created.
The examination number is displayed on the screen.
Pressing Store will store to the microSD card either of these:
• A single frame when in freeze
• A movie when in live
Single frame storage
1. While scanning, press Select to freeze the image and scroll

(Rotate) to the image of interest.
2. Press Store .
The image is stored to the microSD card. A confirmation
message is briefly displayed on screen.

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Using Vscan
Movie storage
1. While scanning or during movie replay, press Store .

The movie is stored to the microSD card. A confirmation
message is briefly displayed on screen.

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Images and voice notations stored on the microSD card can be

recalled for review.
To recall stored data:
1. Press Menu.
through the menu items and highlight Gallery .
3. Press Select.
The Gallery screen is displayed.
4. In the Gallery screen, use / to browse to the desired
examination folder.
5. In the selected examination folder, use / to browse to
the file to open.
The files that can be opened are:
• Single frame image with or without measurements
• movie
• Voice notation
6. Press Select to open the file.
While reviewing a file, use / to review the other files
in the examination.
NOTE: To return to Live scanning, press and hold down Select.

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Using Vscan
Deletion of data
To delete an examination
1. Press Menu.
3. Press Select.
4. In the Gallery screen, use / to browse to the
examination to delete.
5. Press Menu.
6. Use / until Delete exam is highlighted.
7. Press Select.
A confirmation dialog is displayed.
8. Press Select (OK) to delete the examination.
NOTE: The newest active examination cannot be deleted.
To delete a file
1. Press Menu.
3. Press Select.
4. In the Gallery screen, use / to browse to the
examination containing the file to delete.
5. In the selected examination, use / to browse to the
file to delete.
6. Press Menu.
7. Use / until Delete file is highlighted.
8. Press Select.
The file is deleted.

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Chapter 4
Vscan gateway software
Contents:
‘Overview’ on page 4-2
‘Vscan gateway software installation’ on page 4-4
‘Connection of Vscan to a computer’ on page 4-12
‘Using Vscan gateway software’ on page 4-14

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Overview
Data acquired on Vscan can be viewed on a personal computer

after installing the Vscan gateway software, a dedicated viewer
for GE handheld ultrasound scanners. Vscan gateway software
can read data either directly from a connected Vscan (on a
Docking station) or by inserting the Vscan microSD card into a
card reader (not provided) connected to the computer.
The main functionality of Vscan gateway software is:
• Read and display images and movies from the Vscan
scanner
• Playback of audio recorded on Vscan
• Distance and area measurements
• Append images to an E-mail.
• Copy examinations to the computer
• Service functions for connected scanner and Vscan
gateway software: software diagnostics, software updates,
log function.
About the files created in Vscan

Files created on Vscan are stored into examination folders.
Each folder has a unique name consisting the Vscan serial
number, the exam number followed by the date and time of
storage
(<Serial No>_<Exam No>_<yyyymmdd>T<hhmmss>).
Each file has a unique name consisting of the Vscan serial
number, the exam number followed by the date and time when
the exam was started
(<Serial No>_<Exam No>_<yyyymmdd>T<hhmmss>).
The file formats are:
• Still frame: JPEG format
• Movie: MPEG-4 format
• Voice notation: WAV format.

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Overview
CAUTION Do not change the file or folder name. Vscan and Vscan
gateway software will not be able to open a file if the file name
and containing folder name do not match. This is to minimize
the risk of data mix if files are moved inadvertently between
examination folders or renamed in the computer.

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Computer requirements
The minimum requirements for the computer are listed in the
table below
Item Minimum requirements
OS Windows XP Professional SP2 or later

Windows Vista
Windows 7
32-bit and 64-bit versions are supported.
Windows 7 running in VMware Virtualization Software on Mac OS X
10.6 is supported.
CPU Pentium 4 (2.4 GHz) or Pentium M (1.6 GHz)
RAM 1 GB
Disk space 700 MB on system partition

200 MB on partition where program is installed
Graphic DirectX 9c compatible display adapter such as:

• NVIDIA GeForce 6 Series or later
• AMD/ATI X1000 series or later (or Radeon R520 or later)
• Intel GMA X3000 series or later
Min. resolution: 1024x768
Audio Audio output for loudspeakers or earphones
USB At least one USB port available
Pointing device Mouse with left and right buttons
Alphanumeric keyboard Required
CD/DVD player Required
Installed software Windows Media Player version 10

Adobe Acrobat Reader 4.0 or higher (for On line Help function)
Internet Explorer version 7 or higher
Microsoft Outlook (for sending e-mail from Vscan gateway software)
NOTE: The computer running Vscan gateway software should have an

anti virus software installed.
NOTE: Password protection should be used on the computer running
Vscan gateway software, since the software is handling patient
information (e.g. patient name, ID and birthdate).

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CAUTION GE Healthcare has verified and validated the stability and safe
operation of Vscan gateway software on a variety of personal
computers complying with the minimum requirements listed
above. However, be aware that any software running in parallel
with Vscan gateway software may impact the performance of
your computer. In the occurrence of a slow or instable
computer, try to close software which are not required for
clinical purpose.
Installation and activation of Vscan gateway software

Vscan gateway software needs to be installed and activated
before it can be used.
Activation of the Vscan gateway software is only possible after
the Vscan device has been activated. See ‘Vscan activation’ on
page 2-22 if your Vscan is not yet activated.
CAUTION Do NOT attempt to install the Vscan gateway software on

computers running software controlling life-supporting devices.
Do NOT attempt to install the Vscan gateway software on
computers running software monitoring patient condition.
To be able to install the Vscan gateway software the current

Windows user account must have Administrator rights.
Installation of the Vscan gateway software
1. Insert the Vscan gateway software CD into the computer’s

CD-ROM drive.
The installation software starts automatically and a
Welcome window is displayed.

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If the CD does not start automatically, press Start, select

Run and enter X:\setup.exe (where X is the CD drive letter)
in the Run window.
2. Press Next.
The Destination window is displayed.
3. Press Next to install Vscan gateway software to the default

folder or press Browse to install Vscan gateway software to
another location.
The files are being copied and the Complete window is
displayed.

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The computer needs to be restarted before Vscan gateway

software can be used.
4. Press Finish to end the installation and restart the

computer.
Activation of the Vscan gateway software
Activation of the Vscan gateway software is only possible after

the Vscan device has been activated. See ‘Vscan activation’ on
page 2-22 if your Vscan is not yet activated.
The activation consists of entering a specific System ID in your
copy of Vscan gateway software. The System ID is generated
after providing a PIN code to the Vscan web portal.
There are two ways to activate the Vscan gateway software:
• Online activation: generate your System ID from the Vscan
web portal on the Internet as described below.
• Offline activation: contact the GE hotline center to get a
System ID and activates your copy of Vscan gateway
software (see page 4-10).
Online activation
1. Double-click on the Vscan gateway software icon on the
desktop to start the program.
The language window is displayed.

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2. Select your language and press OK.

The Vscan gateway software activation window is
displayed.
3. If not already connected to the Vscan portal, press Connect

to Vscan Portal and login to the site.
(http://vscan.gehealthcare.com)
4. Follow the directions provided in the site to generate the
System ID for the Vscan gateway software.
NOTE: The PIN code displayed in the Vscan gateway software
activation window must be provided in the Vscan web portal
to generate the unique System ID.
5. Copy (Ctrl + c) the System ID generated and go back to the
Vscan gateway software activation window.
6. Paste (Ctrl + v) the System ID in the Vscan gateway
software activation window.
7. Press Next.
The Insite service platform configuration window is
displayed.

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InSite is a communication tool for GE Service that enables

remote diagnostics capability and software upgrade for
Vscan and Vscan gateway software.
8. Press Configure.
The Insite configuration window is displayed.

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All entries in bold in the Insite configuration window must be filled in.
• Continent
• Country
• City
• Institution
• Proxy: Disable unless a proxy server is provided by your institution (contact
the IT administrator).
Fill in the necessary information and press Submit

changes.
Once the configuration is saved close the Insite
configuration window.
9. Press Next and step through the next pages to check the
basic software controls (e.g audio replay, image adjustment
controls and movie controls).
NOTE: Refer to ‘Vscan gateway software troubleshooting’ on
page 6-10 if you experience any issues during the
functionality check.
The Vscan gateway software is now activated and ready for
use.
Offline activation
1. Follow steps 1 and 2 as described in ‘Online activation’ on
page 4-7 to get the PIN code.
2. Write down the PIN code and contact the GE hotline center
to get a System ID for your copy of Vscan gateway.
Tel: see ‘Global ultrasound support center phone numbers’
on page 1-8.
3. Enter the System ID in the Vscan gateway software
activation window and press Next.

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4. Follow steps 7 to 9 as described in ‘Online activation’ on

page 4-7 to resume activation of the Vscan gateway
software.

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CAUTION Accessory equipment connected to the analog and digital

interfaces must be certified according to the respective IEC
standards (e.g. IEC60950 for data processing equipment and
IEC60601-1 for medical equipment). Furthermore all complete
configurations shall comply with the valid version of the system
standard IEC60601-1-1. Anybody who connects additional
equipment to the signal input part or signal output part of Vscan
configures a medical system, and is therefore responsible that
the system complies with the requirements of the valid version
of IEC60601-1-1. If in doubt consult the technical service
department or your local representative for GE Healthcare.
Figure 4-1. Connection setup
1. Place the Vscan on the Docking station.

NOTE: Plug the AC/DC adapter into the electrical outlet to avoid
loss of power during image viewing.
2. Open the display to start the Vscan device.
3. Connect Docking station to the computer using the USB-2
cable.
4. Double-click the Vscan gateway software icon on the
computer desktop to start the application.

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The connected Vscan is automatically detected and

mounted in Vscan gateway software.
NOTE: To disconnect Vscan safely press the Disconnect device
button in the Vscan gateway software Gallery screen or
use the safe removal procedure from Windows.

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Overview
The Vscan gateway software is organized in screens as follows:
1. Gallery screen (default screen), see page 4-15.

2. Setup screen
3. On line documentation screen: displays online
documentation and access to the Vscan web portal.

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Gallery screen
1. List of devices connected to the computer and local storages. Select the device to display the
examinations.
2. List of examinations on the selected device. Select an examination to display the files.
3. List of files (image or voice notation) for the current examination. Select the file to display/listen to.
4. Display of the selected image file.
5. Controls for the selected file: see ‘File specific controls’ on page 4-16.
6. Sort examination by date, patient name or patient ID
Examination filter: filter examinations based on a user defined filter.
7. Gallery Menu
• Open: open a local storage.
• Save as: save the selected examination or file to a folder.
• E-mail: send the selected file(s) by e-mail (Microsoft Outlook required).
8. Image menu
• / : navigate between the files in the current examination
• Dist/Area: distance and area measurement tools
• Annot: annotation tool
• Store: store current image with measurement and annotation
9. Disconnect the device.
Figure 4-2. Gallery screen

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File specific controls
The following controls are available when selecting a file in the

Gallery screen (Figure 4-2).
Still frame controls
Control Description
Contrast Control the amount of contrast.
Brightness Control the amount of brightness.
Movie controls
Control Description
/ Play/Pause Start/stop the movie.
Scroll slider Scroll through the movie by dragging the slider.
/ Backward/Forward Scroll frame by frame through the movie.
/ Start/End Go to start/end of the movie.
Contrast Control the amount of contrast.
Brightness Control the amount of brightness.
Voice notation controls
Control Description
/ Play/Pause Start/stop the voice notation.
Volume slider Adjust the audio volume by dragging the slider.
Scroll slider Scroll through the voice notation by dragging the slider.
Rewind Rewind the voice notation to the beginning.

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Patient information
Patient information can be added to an examination.

1. Right-click on the examination and select Assign patient
information in the context menu.
The Assign patient information screen is displayed.
2. Enter the information and press OK.

The information entered is displayed in the examination list.
Measurements and annotations
Annotations, distance and area measurements can be done on

still frame images, including movie when in pause.
Measurements and annotations are not automatically saved to
disc. Press Store to keep record of the measurements and
annotations.
Distance measurement
1. Select Dist in the Review pane.
2. Left-click to place the first point. Move the mouse to the end
point and left-click to place the end point.
The measurement value is displayed
Area measurement
1. Select Area in the Review pane.
2. Left-click to place the first point. Move the mouse to outline
the area and left-click to place the end point.

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Annotation
1. Select Annot in the Review pane.
2. Move the annotation to the desired location and left-click to
place the annotation. Type the desired text and left-click to
end annotation.
Deletion
Deletion of all measurements and annotations:
1. Right-click on the image and select Delete all
measurements in the context menu.
Single deletion:
1. Place the mouse cursor over the measurement or
annotation to delete.
2. Press Delete on the alphanumeric keyboard.
The annotation or measurement is deleted.
NOTE: It is also possible to right click on the measurement or
annotation to delete and select Delete highlighted
measurement in the context menu.
Deletion of examinations and files
1. Select the examination(s) or file(s) to be deleted.

NOTE: Press Ctrl or Shift while selecting to do multiple selection.
2. Right-click and select Delete in the context menu.
A confirmation message is displayed.
3. Select Yes to confirm deletion.
The selected items are deleted.
Save examinations to the computer
To save an examination or a file from a Vscan to the computer:

1. Select the examination or the file to save and press Save as
.
A Browse window is displayed.
2. Browse to the desired location where to store the files and
press Save.
The local storage is automatically detected by the Vscan
gateway software.

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About local storage

When saving a file to the computer a folder named “Archive” is
created at the selected location. The folder “Archive” contains
the examinations stored in separate folders with unique names.
It is possible to disconnect the local storage to hide it from the

list of devices in the Vscan gateway software.
To disconnect a local storage:
1. Press Disconnect device .
To reconnect the local storage to the Vscan gateway software:
1. Press Open .
A Browse window is displayed.
2. Browse to the desired location, e.g. “My storage” folder and
press OK in the Browse window.
NOTE: This folder should contain a subfolder “Archive” where the
examinations are stored.
The local storage is displayed in the Device list of the Vscan
gateway software.

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Setup screen
This screen is divided in three tabs:
• Home: provide information about the Vscan gateway
software and connected Vscan. From this screen the user
can also:
• Run a wizard to check basic software controls and
configure the Insite service tool.
• Change the language for the Vscan gateway software.
• Send request for service to GE (Hotline).
• Save log file for Vscan gateway software or connected
Vscan.
• Diagnostics: run diagnostic commands on the Vscan
gateway software and connected Vscan.
• Software: install software update for the Vscan gateway
software and connected Vscan.
Service request
NOTE: This feature is not available in Japan.

To send a service request to GE:
1. Press Setup .
2. In the Home page press Contact hotline.
The Contact GE screen is displayed.
3. Fill inn the form. Fields and sections marked with an asterisk
are required.

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4. Press Send.
Generating a log file
In the event of error or system malfunction log files for the Vscan
gateway and any Vscan that has been connected to the
computer are available for GE service through the hotline
system. If not able to send a request by using the Contact
Hotline form in the Setup screen, the user can save log files for
the Vscan gateway software or connected Vscan devices and
send them to GE by other means (for instance by e-mail).
To save a log file:
1. Press Setup .
2. In the Home page press Save Logs.
3. In the Save logs window, enter a description of the problem.

To save the log file to another location, press Browse and
navigate to another location.
4. Press OK.
A zip file is saved. The file can be sent to GE service as an
attachment to an e-mail.
The file naming convention for the log file is:
• Vscan gateway software log file:
<System ID>-LogFile-<yyyy-mm-dd>T<hh-mm-ss>
• Vscan:
<Serial No>-LogFile-<yyyy-mm-dd>T<hh-mm-ss>

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Software update
Software update for the Vscan gateway software and connected

Vscan can be installed from the Setup screen. Available
software updates are automatically detected and an Update
available button is displayed in the upper right corner of the
screen when starting Vscan gateway software.
Vscan gateway software update

1. Press Update available.
The Software page in the Setup screen is displayed
showing the available software update for the selected
device.
2. Select the Vscan gateway software device and press

Install.
The Vscan gateway software is closed and a confirmation
window is displayed.
3. Press OK.
The installation process is started.
4. On the last screen, check the option I would like to launch
Vscan gateway software and press Finnish.
The new version of Vscan gateway software is started.
NOTE: Press Setup , select the Software page and press Delete to
remove the software upgrade that has been installed.
NOTE: The procedure for software update installation from a CD is
similar to the procedure described above.

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Vscan unit software update

1. Place the Vscan on the Docking station. Open the display
2. Press Update available.
The Software page in the Setup screen is displayed
showing the available software update.
3. Select the Vscan device and press Install.
An information window is displayed. Make sure to follow all
the recommendations listed:
• Ensure that the power supply is connected to the
Docking station while upgrading the software.
• DO NOT TURN OFF the Vscan unit while upgrading the
software.
CAUTION Do not turn off or disconnect power during the update.

Doing so could cause an error requiring the device to be
sent for repair.
4. Press OK.
The software update files are copied and unpacked to the
Vscan microSD card.
5. The Vscan is running a system test.
• If the test failed, close the display to turn off the system
and contact service.
• If the test passed, the software update is installed. This
may take several minutes.
The following messages are displayed on screen.
When the installation is done, the Vscan is turned off

automatically. Close the display.
6. Open the display to restart the Vscan.
The Vscan is running a system test.

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• If the test passed the Vscan is ready for use.
NOTE: The next time the Vscan is docked to the Vscan gateway
software, pressing Delete in the Software page will remove the
installed upgrade from the list.
Vscan unit software update from a microSD card

If the software update is provided on a microSD card, proceed
as follows:
1. Make sure the battery is fully charged.
2. Remove the Archive microSD card from the Vscan (see
page 2-17).
3. Insert the Update microSD card in the Vscan (see
page 2-18).
4. Place Vscan on the Docking station and make sure that the
power supply is connected to the Docking station.
• If the test passed the Consult user documentation
screen is displayed.
6. Press Store and Color simultaneously to start the

installation.
CAUTION Do not turn off the Vscan during the update. Doing so could
cause an error requiring the device to be sent for repair.

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The unit is turned off automatically when the installation is

completed. Close the display.
7. Remove the Update microSD card from the Vscan and
reinsert the Archive microSD card.
8. Open the display to restart the Vscan.
• If the test passed the Vscan is ready for use.

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Chapter 5
Vscan configuration
Contents:
‘Config menu’ on page 5-2

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Vscan configuration
Config menu
The following settings and functions are available from the

Config menu.
Item Choice Note
Language English, Norwegian, German,

Dutch, Italian, French, Spanish,
Portuguese, Russian, Greek,
Danish, Swedish, Japanese and
Setup Chinese
Date dd / MM / yy Set current date
Date format dd / mmm / yy 01 / AUG / 09

dd / mmm / yyyy 01 / AUG / 2009
dd / mm / yy 01 / 08 / 09
mm / dd / yyyy 08 / 01 / 2009
mm / dd / yy 08 / 01 / 09
mm / dd / yyyy 08 / 01 / 2009
Time hh:mm:ss Set current time
Time format 12 h
24 h
Auto Freeze 1, 3 or 5 min. The Vscan enters in Freeze

if idle for the time set.
Reset exam OK, Cancel The microSD card must be

number empty to reset the exam
number to one.
Brightness Adjust monitor brightness. Adjust brightness so that all

Rotate to adjust brightness and the tones from the darkest to
press Select. the lightest can be
distinguished.
Test System diagnostics wizard to Requires a restart of the

test the Vscan control unit and Vscan.
the probe.
About Displays system information This information may be

(hardware and software) required when contacting GE
service.

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Config menu
Item Choice Note
Shutdown System shutdown procedure

to use when cleaning Vscan.
Activation Displays the Activation key

screen (see page 2-23)
System setup adjustment

1. Press Menu.
through the menu items and highlight Config ( ).
3. Press Select.
The Config menu is displayed.
and highlight Setup .
5. Press Select.
The Setup screen is displayed.
6. Use / to highlight the item to adjust.

7. Press Select and use / to adjust the setting.
8. Press Select to confirm the adjustment.
NOTE: For settings with multiple parameters (e.g. date and time),
use / to navigate between the parameters.

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Vscan configuration

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Chapter 6
Vscan maintenance
Contents:
‘System care and maintenance’ on page 6-2
‘Inspection’ on page 6-3
‘Cleaning and disinfection’ on page 6-4
‘Reinstallation of the factory software’ on page 6-7
‘Troubleshooting’ on page 6-9

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Vscan maintenance
System care and maintenance
CAUTION The user must ensure that safety inspections are performed at
least every 12 months according to the requirements of the
patient safety standard IEC 60601-1 / UL60601-1.
Only trained persons are allowed to perform the safety
inspections mentioned above.
The Vscan requires regular care and maintenance to function

safely and properly.
To ensure that the Vscan constantly operates at maximum
efficiency we recommend that the following procedures be
observed as part of the customer’s internal routine maintenance
program.

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Inspection
Inspection
Inspecting the Vscan
CAUTION If any defects or damages are found on the control unit, the
probe or its cable, DO NOT use the Vscan. Contact GE
service.
Examine the following on a monthly basis (or whenever there is

a reason to assume that any issue may have occurred):
• Connectors on cables, for any mechanical defects
• Entire length of electrical cables, for cuts or abrasions
• Equipment, for loose or missing hardware
WARNING To avoid electrical shock hazard, do not remove covers from

the Vscan.
Inspecting the probe
CAUTION If any defects or damages are found on the probe or its cable,
DO NOT use the Vscan. Contact GE service.
Before each use
1. Inspect the lens, the probe housing and the cable.

2. Look for damage that might allow liquid into the probe.
3. Test the functionality of the probe.

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Vscan maintenance
Cleaning
Cleaning the control unit, the display and the Docking station
Make sure the Docking station is disconnected from the AC

adapter before cleaning.
1. Switch off the Vscan from the Shutdown menu (see
page 3-2).
2. Moisten a soft, non-abrasive cloth with a mild, general
purpose, non-abrasive soap and water solution.
3. Wipe the Vscan and the Docking station.
4. Wipe dry with a soft towel.
CAUTION Do not spray any liquid directly onto the Vscan or the Docking
station.
NOTE: DO NOT scratch or press on any part of the Vscan with any
sharp objects, such as pencils or pens, as this may result in
damage of the Vscan.
Cleaning the probe
1. Remove the coupling gel by wiping the probe lens with a

soft cloth.
2. Wipe the probe and cable with a soft cloth moisten in a
warm soap and water solution (<80 oF/27 oC).
3. Wipe the probe and cable with a soft cloth moisten in clean
water (<80 oF/27 oC) until all soap is removed.
4. Wipe dry with a soft towel.

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Disinfection
Recommended germicides
In order to provide users with options in choosing a germicide,

GE Healthcare routinely reviews new medical germicides for
compatibility with the Vscan and its probe. Although a necessary
step in protecting patients and employees from disease
transmission, liquid chemical germicides must also be selected
to minimize potential damage to the transducer.
The following germicides can be used on the Vscan and its
probe.
T-Spray Pharmaceutical Innovations
T-Spray II Pharmaceutical Innovations
CaviWipes Metrex
Cleanisept wipes Dr. Schumacher GmbH
Sani-Cloth HB PDI
Septiwipes Dr. Schumacher GmbH
WARNING Use only compatible germicides. In addition, refer to the local /

national regulations.
Never use thinner, benzene, alcohol (ethanol, methanol, or
isopropyl alcohol), abrasive cleaners, or other strong solvents,
as these may cause damage to the control unit, the display or
the probe.
NOTE: Follow the manufacturer's instructions for storage, use and

disposal of the disinfection solution.
Disinfecting the control unit
1. After cleaning, the control unit may be wiped with a tissue

sprayed with a recommended germicide.

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Vscan maintenance
Disinfecting the probe
1. After cleaning, the probe and cable may be wiped with a

tissue sprayed with a recommended germicide.
WARNING Use additional precautions (e.g. gloves and gown) when

decontaminating an infected probe.
The probe should not be exposed to the germicide longer than
specified to achieve the desired effect.
DO NOT soak or saturate the probe with solutions containing
alcohol, bleach, ammonium chloride compounds or hydrogen
peroxide.
WARNING CREUTZFELD-JACOB DISEASE

Neurological use on patients with this disease must be
avoided. If the Vscan becomes contaminated, there is no
adequate disinfecting means.

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A microSD card with the factory software is provided in a sealed

envelope in case a clean re-installation of the factory software is
required.
CAUTION IMPORTANT!
Reinstallation of the factory software should only be done
in agreement with service.
Procedure
1. Make sure the battery is fully charged.
2. Remove the Archive microSD card from the Vscan (see
page 2-17).
3. Insert the Factory software microSD card in the Vscan (see
page 2-18).
4. Place Vscan on the Docking station and make sure that the
power supply is connected to the Docking station.
After about 30 seconds, the Consult user documentation
screen is displayed.
6. Press Store and Color simultaneously to start the

installation.

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Vscan maintenance
CAUTION Do not turn off the Vscan or disconnect the power supply
during the installation. Doing so could cause an error
requiring the device to be sent for repair.
The unit is turned off automatically when the installation is

completed.
7. Remove the Factory software microSD card from the Vscan
and reinsert the Archive microSD card.
The Vscan is now reset with the factory software and needs
to be activated again (see ‘Vscan activation’ on page 2-22).

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Troubleshooting
Troubleshooting
Vscan troubleshooting
Problem Possible cause Solution
Vscan has no power. Battery not inserted. Insert battery (see page 2-15).
Battery not charged Charge the battery (see

page 2-11)
Battery defect or end of life Contact GE Service (see

page 1-7).
Broken battery connection Contact GE Service (see

page 1-7).
Vscan is not charging. Battery not inserted. Insert battery (see page 2-15).
Battery defect or end of life Contact GE Service (see

page 1-7).
Broken battery connection Contact GE Service (see

page 1-7).
Defect AC adapter or charger Contact GE Service (see

page 1-7).
Mains power is down.
Temperature is outside the Ensure the ambient temperature

specified limits is within the specified limits (see
page i-3)
When opening the display, the Connection broken during Contact GE Service (see
screen is white and nothing is software loading. page 1-7).
happening.
Parts of the image is missing Channels are missing Contact GE Service (see
when scanning. page 1-7).
Noise when moving the probe Defect probe cable Contact GE Service (see
cable page 1-7).
No image displayed when Defect probe Contact GE Service (see

scanning page 1-7).

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Vscan maintenance
Vscan gateway software troubleshooting
No connection between Vscan is not properly docked on Ensure the Vscan is properly docked.
Vscan and Vscan the docking station.
gateway software
The Docking connectors on the Verify that the docking connectors on the
Vscan and the Docking station Vscan and on the Docking station are
are dirty. clean. Remove any dust or foam rests
from the connectors.
Vscan is not turned on. Ensure that the Vscan is turned on (see
page 3-2).
The microSD card is not inserted Make sure the microSD card is properly
properly, or missing. inserted (see page 2-17).
USB cable is not connected. Make sure the USB cable is properly
connected in both ends.
USB port on the PC is defect. Try another USB port on the PC.
Vscan movies are not The display adapter requirements See ‘Computer requirements’ on
playing in Vscan gateway are not met. page 4-4.
software.
The display adapter driver is not Update the display adapter driver to the
up-to-date. latest version. New driver can be
obtained from the computer or display
adapter manufacturer.
Hardware acceleration for the Turn on hardware acceleration for the

display adapter is turned off. display adapter. This can be done in the
display adapter Control panel /
Properties dialog
• Windows Vista: Control Panel /
Appearance and Personalization /
Adjust Screen Resolution / Advanced
Settings
• Windows XP: Control Panel / Display /
Settings / Advanced
Direct 3D Acceleration is Turn on Direct3D Acceleration.

disabled. 1. Press Start and select Run.
2. Type DxDiag and press OK.
3. Select the Display tab and verify
that the Direct3D Accelerator is
turned on.
Desktop sharing or remote This type of program may influence the

desktop softwares (e. g. display of Vscan movie in Vscan
NetMeeting) are running. gateway software. Try to close this type
of program when using Vscan gateway
software.

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Troubleshooting
Vscan display is flashing Automatic reduction of the frame Restart the Vscan to enable normal
while scanning rate due to increase of the frame rate again. To help keeping the
operating temperature after Vscan operating temperature at an
extended scanning. optimal functional level, and to ensure
longer scanning time with maximum
frame rate, it is recommended to hold the
Vscan so that there is good contact
between the device and the hand.

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Vscan maintenance

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Chapter 7
Safety
Contents
‘Introduction’ on page 7-2
‘Owner responsibility’ on page 7-3
‘Important safety considerations’ on page 7-5
‘Probe overview’ on page 7-19
‘Maximum probe temperature’ on page 7-20
‘Device labels and symbols’ on page 7-21

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Safety
Introduction
This chapter describes the important safety measures which

should be taken before operating the Vscan. Procedures for
simple care and maintenance of the Vscan are also described.
Various levels of safety precautions may be found on the
equipment, and different levels of severity are identified by one
of the following icons that precede precautionary statements in
the text.
The following icons are used to indicate precautions:
DANGER Indicates that a specific hazard exists that, given inappropriate

conditions or actions, will cause:
• Severe or fatal personal injury
• Substantial property damage
WARNING Indicates that a specific hazard exists that, given inappropriate

conditions or actions, will cause:
• Severe or fatal personal injury
• Substantial property damage
CAUTION Indicates that a potential hazard may exist that, given

inappropriate conditions or actions, can cause:
• Minor injury
• Property damage

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It is the responsibility of the owner to ensure that anyone

operating the Vscan reads and understands this section of the
manual. However, there is no representation that the act of
reading this manual renders the reader qualified to operate,
inspect, test, align, calibrate, troubleshoot, repair or modify the
system. The owner should make certain that only properly
trained, fully-qualified service personnel undertake the
installation, maintenance, troubleshooting, calibration and repair
of the equipment.
The owner of the Vscan should ensure that only properly
trained, fully qualified personnel are authorized to operate the
system. Before authorizing anyone to operate the system, it
should be verified that the person has read, and fully
understands, the operating instructions contained in this
manual. It is advisable to maintain a list of authorized operators.
Should the system fail to operate correctly, or if the Vscan does
not respond to the commands described in this manual, the
operator should contact the nearest field GE Ultrasound Service
Office.
For information about specific requirements and regulations
applicable to the use of electronic medical equipment, consult
the local, state and federal agencies.
CAUTION For USA only:

Federal law restricts this device to use by, or on the orders of, a
physician.
CAUTION This Vscan should be used in compliance with law. Some

jurisdictions restrict certain uses, such as gender
determination.
Notice against user modification

Never modify this product, including system components,
cables, and so on. User modification may cause safety hazards

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Safety
and degradation in system performance. All modification must

be done by a GE qualified person.
Software upgrade following GE recommendations can be done
by the user.

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This section includes considerations for the following:

• Patient safety
• Personnel and equipment safety
The information contained in this section is intended to
familiarize the user with the hazards associated with the use of
the Vscan, and to alert them to the extent to which injury and
damage may occur if the precautions are not observed.
Users are obligated to familiarize themselves with these safety
considerations and to avoid conditions that could result in injury
or damage.
Patient safety
Patient identification
WARNING The concerns listed in this section can seriously affect the
safety of the patient undergoing a diagnostic ultrasound
examination.
Always include proper identification with all patient data. It is

recommended to use voice notation to identify the patient.
Identification errors could result in an incorrect diagnosis.
If the Vscan needs to be sent for repair, ensure that any patient
information is erased from the microSD card, or that the
microSD card is removed from the Vscan before shipping. In
case that any patient information is still residing on the Vscan,
GE will contact the customer and request for urgent collection of
that patient information. GE will keep this patient information in a
secure environment for a maximum period of one month. All
patient information will be permanently deleted at that point.

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Safety
CAUTION Be certain to ensure privacy data of patient information.
Diagnostic information
The images and calculations provided by the system are

intended for use by competent users, as a diagnostic tool. They
are explicitly not to be regarded as the sole, irrefutable basis for
clinical diagnosis. Users are encouraged to study the literature
and reach their own professional conclusions regarding the
clinical utility of the system.
The user should be aware of the product specifications and of
the system accuracy and stability limitations. These limitations
must be considered before making any decision based on
quantitative values. If in doubt, the nearest GE Ultrasound
Service Office should be consulted.
Equipment malfunction or incorrect settings can result in
measurement errors or failure to detect details in the image. The
user must become thoroughly familiar with the operation of the
Vscan in order to optimize its performance and to recognize
possible malfunctions. Application training is available through
the sales representative.
General precautionary advice for the use of diagnostic ultrasound in

combination with ultrasound contrast agents
CAUTION Cardiac rhythm disturbances during cardiac studies using gas

ultrasound contrast agents have been observed in the
diagnostic range of Mechanical Index (MI) values. See the
specific package insert for the contrast agent being used for
further details.
Mechanical hazards
A damaged probe may result in injury or increased risk of

infection. Inspect the probe frequently for sharp, pointed or
rough surface damage that could cause injury or tear protective
barriers (gloves and sheaths).

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Electrical Hazard
A damaged probe may increase the risk of electric shock if

conductive solutions come in contact with internal live pads.
Inspect the probe often for cracks or openings in the housing
and holes in and around the acoustic lens, or other damage that
could allow moisture to enter. Become familiar with the probe's
care precautions outlined in ‘Vscan maintenance’ on page 6-1.
Personnel and equipment safety
DANGER The hazards listed below can seriously affect the safety of
personnel and equipment during a diagnostic ultrasound
examination.
Explosion hazard
Never operate the equipment in the presence of flammable or

explosive liquids, vapors or gases. Malfunctions in the Vscan, or
sparks, can electrically ignite these substances. Operators
should be aware of the following points to prevent such
explosion hazards.
• If flammable substances are detected in the environment,
do not plug in or turn on the system.
• If flammable substances are detected after the system has
been turned on, do not attempt to turn off the Vscan, or to
unplug it.
• If flammable substances are detected, evacuate and
ventilate the area before turning off the Vscan.
Electrical hazard
WARNING The internal circuits of the AC/DC adapter use high voltages,
capable of causing serious injury or death by electrical shock.
NOTE: Any rest energy within our scanners or their components will be
below 60 V DC or 2 mJ.

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Safety
To avoid injury
• Do not remove the Vscan's protective covers. No
user-serviceable parts are inside. If servicing is required,
contact GE service.
• Do not spray or place liquids on or above the Vscan.
Conductive fluids seeping into the active circuit components
may cause short circuiting, which could result in an electrical
fire.
Pacemaker hazard
The possibility of the system interfering with pacemakers is

minimal. However, as this system generates high frequency
electrical signals, the operator should be aware of the potential
hazard this could cause.
Electrical safety
Device classifications
The Vscan is an internally powered device, type BF.
The AC/DC adapter is Class II.
External Connection
CAUTION Connection to a PC can be done when the PC is in compliance

with the IEC standard EN 60950 (Data processing equipment).
The computer connected to Vscan must be kept outside the
patient environment (refer to local regulation and EN 60601-1).

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1. Patient environment
Figure 7-1. Patient environment
Allergic reactions to latex-containing medical devices
Due to reports of severe allergic reactions to medical devices

containing latex (natural rubber), the FDA advises health-care
professionals to identify latex-sensitive patients, and be
prepared to treat allergic reactions promptly. Latex is a
component of many medical devices, including surgical and
examination gloves, catheters, incubation tubes, anesthesia
masks and dental dams. Patient reaction to latex has ranged
from contact urticaria, to systemic anaphylaxis.
For more details regarding allergic reaction to latex, refer to FDA
Medical Alert MDA91-1, March 29.
Electromagnetic Compatibility (EMC)

NOTE: This unit carries the CE mark. It complies with regulatory
requirements of the European Directive 93/42/EEC concerning
medical devices. It also complies with emission limits for a
Group 1, Class B Medical Device as stated in EN 60601-1-2
(IEC 60601-1-2).
Electrical medical equipment needs special precautions
regarding EMC and needs to be installed and put into service
according to the EMC information provided in this manual.

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Safety
AII types of electronic equipment may characteristically cause

electromagnetic interference with other equipment, transmitted
either through air or connecting cables. The term
Electromagnetic Compatibility (EMC), indicates the capability of
the equipment to curb electromagnetic influence from other
equipment, while at the same time not affecting other equipment
with similar electromagnetic radiation.
Radiated or conducted electromagnetic signals can cause
distortion, degradation, or artifacts in the ultrasound image
which may impair the ultrasound unit’s essential performance
(see page 7-15).
There is no guarantee that interference will not occur in a
particular installation. If this equipment is found to cause or
respond to interference, attempt to correct the problem by one
or more of the following measures:
• Re-orient or re-locate the affected device.
• Increase the separation between the unit and the affected
device.
• Power the equipment from a source other than that of the
affected device.
• Consult the service representative for further suggestions.
The manufacturer is not responsible for any interference or
responses caused by the use of interconnecting cables other
than those recommended, or by unauthorized changes or
modifications to this unit. Unauthorized changes or
modifications could void the user's authority to operate the
equipment.
To comply with the regulations on electromagnetic interference,
all interconnecting cables to peripheral devices must be
shielded and properly grounded. Use of cables not properly
shielded and grounded may result in the equipment causing or
responding to radio frequency interference, in violation of the
European Union Medical Device Directive and FCC regulations.
Devices which intrinsically transmit radio waves such as cellular
phones, radio transceivers, mobile radio transmitters,
radio-controlled toys, and so on, should preferably not be
operated near the unit. See page 7-15 about the recommended
minimum separation distances between portable and mobile RF
communications equipment and the ultrasound unit.
Any electrical device can unintentionally emit electromagnetic
waves. However, minimum device separation distances cannot
be calculated for such unspecified radiation. When the
ultrasound unit is used adjacent to or in close proximity to other

GM092102 05
equipment the user should be attentive to unexpected device

behavior which may be caused by such radiation.
The ultrasound unit is intended for use in the electromagnetic
environment specified in the tables below.
The user of ultrasound unit should assure that the device is
used in such an environment.

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Safety
Electromagnetic emissions
Guidance and manufacturer’s declaration – electromagnetic emissions.
Emissions test Compliance Electromagnetic environment - guidance
RF emission Group 1 The ultrasound unit uses RF energy only for its internal
CISPR 11 function. Therefore, its RF emissions are very low and
EN55011 are not likely to cause any interference in nearby
electronic equipment.
RF emission Class B The ultrasound unit is suitable for use in all

CISPR 11 establishments, including domestic establishments and
EN55011 those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic
Harmonic emission Class A purposes.
IEC 61000-3-2
Voltage fluctuations/flicker Complies

emissions
IEC 61000-3-3
Electromagnetic immunity
Guidance and manufacturer’s declaration – electromagnetic immunity.
Electromagnetic
IEC 60601 environment –
Immunity test test level Compliance level guidance
Electrostatic discharge Floors should be wood,

(ESD) ±6 kV contact ±6 kV concrete or ceramic tile. If
floors are covered with
IEC 61000-4-2 ±8 kV air ±8 kV synthetic material, the
relative humidity should be
at least 30%.
Electrical transients / ±2 kV for power-supply ±2 kV Mains power quality should

bursts lines be that of a typical
IEC 61000-4-4 commercial or hospital
±1 kV for input/output ±1 kV environment.
lines
Surge ±1 kV line(s) to line(s) ±1 kV Mains power quality should

be that of a typical
IEC 61000-4-5 ±2 kV line(s) to earth ±2 kV commercial or hospital
environment.

GM092102 05
Guidance and manufacturer’s declaration – electromagnetic immunity.
Electromagnetic
IEC 60601 environment –
Immunity test test level Compliance level guidance
< 5% UT
(>95% dip in UT) for Compliance for all Mains power quality should
0.5 cycle test levels. be that of a typical
Voltage dips, short 40% UT commercial or hospital
interruptions and Controlled shutdown environment. If the user of
(60% dip in UT) for
voltage variations on with return to the ultrasound unit requires
5 cycles
power supply input lines pre-disturbance continued operation during
condition after power mains interruptions, it
70% UT
IEC 61000-4-11 operator’s is recommended that the
(30% dip in UT) for intervention. ultrasound unit is powered
25 cycles (Power-on switch) from an uninterruptible
power supply or a battery.
< 5% UT
(>95% dip in UT) for
5 sec.
Power frequency (50/ Power frequency magnetic

60 Hz) magnetic field fields should be at levels
3 A/m 3 A/m characteristic of a typical
IEC 61000-4-8 50 and 60 Hz location in a typical
commercial or hospital
environment.
NOTE: UT is the a. c. mains voltage prior to application of the test level.

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Safety
Guidance and manufacturer’s declaration – electromagnetic immunity
IEC 60601 test Compliance Electromagnetic

Immunity test level level environment – guidancec
Portable and mobile RF

communications equipment should be
used no closer to any part of the
ultrasound unit, including cables, than
the recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance
Conducted RF 3 Vrms 3 Vrms [V1]
IEC 61000-4-6 150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz

Conducted RF
IEC 61000-4-3 3 V/m 3 V/m [E1]
80 MHz to 2.5 GHz where p is the maximum output power

rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation distance in
metres (m).b
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,a should
be less than the compliance level in
each frequency range.b
Interference may occur in the vicinity of
equipment marked with the following
symbol
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic is affected by absorption and
reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the
ultrasound unit is used exceeds the applicable RF compliance level above, the ultrasound unit should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the ultrasound unit.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
c See examples of calculated separation distances in next table.

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Separation distances
Recommended separation distances between portable and mobile RF communications

equipment and the ultrasound unit
The ultrasound unit is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the ultrasound unit can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the ultrasound unit as recommended below, according to the
maximum output power of the communications equipment.
Separation distance according to frequency of transmitter

m
Rated maximum output 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
of transmitter
W
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above the recommended separation distance d
in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is
the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
Essential Performance
The essential performance of the Vscan is:

• The ability to display physiological images as input for
diagnosis by trained physician.
• The ability to display quantified data as input for diagnosis
by trained physician.
• The display of ultrasound indexes as aid for safe use of the
Vscan.

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Safety
Acoustic output
Definition of the acoustic output parameters
Thermal Index
TI is an estimate of the temperature increase of soft tissue or
bone. There are three thermal index categories:
• TIS: Soft tissue thermal index. The main TI category. Used
for applications that do not image bone.
• TIB: Bone thermal index (bone located in a focal region).
Used for fetal application.
• TIC: Cranial bone thermal index (bone located close to the
surface). Used for transcranial application.
Reference to calculation of TI can be found in:
• NEMA Standards Publication UD 3: “Standard for Real-Time
Display of Thermal and Mechanical Acoustic Output Indices
on Diagnostic Ultrasound Equipment”, Revision 2
• IEC 60601-2-37. Medical electrical equipment. Part 2-37:
Particular requirements for the safety of ultrasonic medical
diagnostic and monitoring equipment
Mechanical Index
MI is the estimated likelihood of tissue damage due to cavitation.
The absolute maximum limits of the MI is 1.9 as set by the FDA
510(k) guidance of September 9, 2008.
Ispta
The Ispta is the Spatial Peak Temporal Average Intensity. The
absolute maximum limit of Ispta is 720 mW/cm2 as set by the
FDA 510(k) guidance of September 9, 2008.
Acoustic output and display on the Vscan
MI and TI values are displayed on the scanning screen. For all

imaging modes of Vscan, TIS equals TIB and is displayed as TI.
The Vscan chooses the correct category based on mode of
operation and chosen application, and presents only one TI to
the operator. It is therefore important that the operator chooses
the right application.
The maximum possible MI and Ispta on the Vscan is within the
limits set in Track 3 in the FDA 510(k) guide of September 9,
2008, MI <1.9 and Ispta <720 mW/cm2.

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Display Accuracy and Acoustic Measurement Uncertainties

The display accuracy and measurement precision of the output
display are summarized in the table below. Accuracy of the
output display (TI, MI) parameters depends on the
measurement system precision, the acoustic model used to
calculate the parameters and variation in the acoustic output of
probes and systems. The measurement precision and overall
accuracy of the measurements have been assessed by
determining both the random and the systematic uncertainties
and given in percent at 95% confidence level.
Parameter Estimated accuracya Measurement precision
black and white/color
Pressure, MI ±25% ±15%
Power, TI ±50% ±40%
a. Accuracy = (Measured value - displayed value)/displayed

value * 100%
System controls affecting acoustic output
The operator controls that directly affect the acoustic output are
discussed in the Acoustic Output Data Tables (see page 8-1).
These tables show the highest possible acoustic intensity for a
given mode, obtainable only when the maximum combination of
control settings is selected. Most settings result in a much lower
output. It is important to note the following:
• The duration of an ultrasound examination is as important
as the acoustic output, since patient exposure to output is
directly related to the exposure time.
• Better image quality yields faster clinical results, making it
possible to complete the relevant ultrasound examination
more rapidly. Therefore, any control that improves the
quality of the examination can help to reduce patient
exposure, even though it may not directly affect acoustic
output.
Application selection
Selecting the application appropriate to a particular ultrasound
examination automatically provides acoustic output limits within
FDA guidelines for that application. Other parameters which
optimize performance for the selected application are also set

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Safety
automatically, and should assist in reducing the patient

exposure time.
Changing imaging modes

Acoustic output depends on the imaging mode selected. The
choice of mode (black and white or color imaging) determines
whether the ultrasound beam is stationary or in motion. This
greatly affects the energy absorbed by the tissue (see ‘Acoustic
Output Reporting Tables’ on page 8-2 for TI and MI values in
black and white or color imaging.
ALARA
Ultrasound procedures should be performed using output levels

and exposure times As Low As Reasonably Achievable
(ALARA) while acquiring clinical information.
Training
During each ultrasound examination the user is expected to
weigh the medical benefit of the diagnostic information that
would be obtained against the risk of potential harmful effects.
Once an optimal image is achieved, the need for increasing
acoustic output or prolonging the exposure cannot be justified. It
is recommended that all users receive proper training in
applications before performing them in a clinical setting. Contact
the GE Healthcare sales representative for training assistance.
Track 3 ALARA Educational Program

The user should be familiar with the document “Medical
Ultrasound Safety”, published by AIUM (American Institute of
Ultrasound in Medicine), see page 8-8. This document is
acceptable to FDA as meeting the content of the ALARA
educational program. In addition to the AIUM document, the
sections ‘Acoustic output and display on the Vscan’ on
page 7-16 and ‘System controls affecting acoustic output’ on
page 7-17 should be studied carefully in order to implement
ALARA.
Environmental protection
System disposal
The device must not be destroyed by incineration. Please return

the device to your local GE Healthcare representative for
disposal.

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Probe overview
Probe overview
Probe Mode Technical data
G3S Black and white Frequency: 1.7–3.8 MHz

Color Foot print: 13 x 19 mm

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Safety
Maximum probe temperature
Max Temp Max Temp

Probe (Simulated use) (Still air)
G3S 38.5 40.2
NOTE: Lens temperature measured under following conditions per

IEC 60601-2-37:
1. Thermocouple was placed at the geometric center of the
lens.
2. a: Thermal phantom at 37 °C for non-external probes.
b: Thermal phantom at 33 °C (or 23 °C) for external probes.
(Temperature rise is measured and added to 33 °C if the
phantom is at 23 °C).
NOTE: Thermal phantom made with tissue-mimicking material as
referenced in IEC 60601-2-37.
3. Probe placed upright in contact with above thermal
phantom.
4. Auto-freeze capability is disabled.
5. Lens temperature is monitored for 30 minutes.

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The following table describes the purpose of safety labels and

other important information provided on the equipment.
Label Purpose Location
CE mark Vscan control unit
This symbol indicates that the waste of Vscan control unit

electrical and electronic equipment must Vscan AC adapter
not be disposed as unsorted municipal Vscan battery (GM-BAT)
waste and must be collected separately.
Please contact the manufacturer or other
authorized disposal company to
decommission your equipment.
Follow instructions for use. Read and Vscan control unit

understand all instructions in the User's
Manual before attempting to use the
ultrasound unit.
TÜV NRTL mark Vscan control unit
Equipment Class II for products not relying Vscan AC adapter

protective earth such as products having
double or reinforced insulation.
Type BF Applied Part symbol (see Vscan control unit

page i-3).
Direct Current Vscan control unit

Vscan AC adapter
Alternating current Vscan AC adapter
Output, use only on Vscan device. Vscan Docking station

Vscan battery charging
compartment
Vscan charger (GM-CHA)
Input, use only Vscan charger (GM-CHA). Vscan control unit

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Safety
Label Purpose Location
Rechargeable, use only Vscan battery Vscan control unit

(GM-BAT). Vscan Docking station
AC adapter and charger Plastic bag containing the

Vscan AC adapter and charger
Manufacturer address Vscan control unit

Vscan battery (GM-BAT)
Manufacturing date (month/year) Vscan control unit
MFD Manufacturing date (yymmdd) Vscan AC adapter
Part number Vscan control unit
Serial number Vscan control unit
Batch number Vscan Docking station

Vscan battery charging
compartment
Vscan charger (GM-CHA)
For indoor use only Vscan AC adapter
Do not expose the battery to direct flame. Vscan battery (GM-BAT)
Do not attempt to disassemble the battery. Vscan battery (GM-BAT)

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Chapter 8
Appendix
Contents:
‘Acoustic Output Reporting Tables’ on page 8-2
‘Measurement accuracy’ on page 8-7
‘Medical Ultrasound Safety’ on page 8-8

GM092102 05
Appendix
Definitions, symbols and abbreviations

The following definitions, symbols and abbreviations are used in
the acoustic output reporting tables in this chapter:
IEC FDA Meaning—IEC 60601-2-37 / FDA & NEMA UD2, UD3
Acoustic Attenuation Coefficient / Derating factor (usually 0.3 dB/cm-MHz)
-12db Output Beam Area / Active aperture area
Normalizing Coefficient
Equivalent Aperture Diameter / (same)
Pulse Beam Width / Beam diameter at –6 dB
Equivalent Beam Diameter
Acoustic Working Frequency / Center frequency
Pulse-Average Intensity
Attenuated Pulse-Average Intensity
Pulse-Intensity Integral
Attenuated Pulse-Intensity Integral
Temporal-Average Intensity
Attenuated Temporal-Average Intensity / (at depth z)
Spatial-Peak Temporal-Average Intensity
Attenuated Spatial-Peak Temporal-Average Intensity
Mechanical Index
Output Power / Time average acoustic power at the source
Attenuated Output Power / Time average acoustic power derated to depth z
Bounded Output Power / Power emitted from the central 1cm of aperture

GM092102 05
IEC FDA Meaning—IEC 60601-2-37 / FDA & NEMA UD2, UD3
Pulse Pressure Squared Integral / Pulse intensity integral
Peak-Rarefactional Acoustic Pressure / (same)
Attenuated Peak-Rarefactional Acoustic Pressure / (same)
Pulse Repetition Rate / Pulse repetition frequency
Thermal Index / (same)
Bone Thermal Index / (same)
Cranial-Bone Thermal Index / (same)
Soft-Tissue Thermal Index / (same)
Pulse Duration / (same)
-12 dB Output Beam Dimensions / (same)
Distance from the Source to a Specified Point / (same)
Depth for TIB / Depth at which the relevant index is maximum
Break-Point Depth / (same)
Depth for TIS / Depth at which the relevant index is maximum
Explanation of Footnotes
The mechanical and thermal indices may be replaced by one of

the following footnotes because of the reasons listed:
• a: Display of this index is not required for this operating
mode.
• b: This probe is not intended for transcranial or neonatal
cephalic uses.
• c: This formulation for TIS is less than that for an alternate
formulation in this mode.
If so, the table entries are replaced by a “#”, meaning: no data
are provided for this operating condition since the maximum
reported value is not reported for the reason listed.
If neither an index or a footnote is given, this means that the
index is irrelevant for this transducer/mode combination.

GM092102 05
Appendix
Operating Conditions
All table entries are with the operating conditions specified at the
end of the table.

GM092102 05
Acoustic Output Reporting Tables for Track 3/IEC 60601-2-37
Transducer Model: G3S
Operating Mode: black and white
See explanation of measurements on page 8-3.

GM092102 05
Appendix
Transducer Model: G3S

Operating Mode: color

GM092102 05
The measurement accuracy of the system is validated on

images of an ultrasound phantom with speed of sound of
1540 +/-10 m/s. For in-vivo ultrasound images the accuracy may
be slightly reduced due to variations of the speed of sound in
different kinds of tissue.
Distance measurement
The distance measurement accuracy is 1% of the total displayed
depth of the recording. For example an image with a total depth
of 16 cm will have a measurement accuracy of +/-1.6 mm.
Area measurement
The area measurement accuracy is 10% of the measured area
for areas larger than 1 cm2. For areas smaller than 1 cm2 the
measurement accuracy is +/-0.1 cm2.

GM092102 05
Appendix
The user should be familiar with the enclosed document

“Medical Ultrasound Safety”, published by AIUM (American
Institute of Ultrasound in Medicine). This document is
acceptable to FDA as meeting the content of the ALARA
educational program. ALARA is an acronym for the principle of
prudent use of diagnostic ultrasound by obtaining the diagnostic
information at an output that is As Low As Reasonably
Achievable.
NOTE: This document is only available in English.
To contact the AIUM concerning their publications:
American Institute of Ultrasound in Medicine Laurel, Maryland
20707-590
14750 Sweitzer Lane, Suite 100
Phone: 301-498-4100 or 800-638-5352
Fax: 301-498-4450

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Index
A M
Auto freeze, 3-8 Maintenance, 6-1
AutoCycle, 3-8 MicroSD card
Insert, 2-17
B Installation, 2-21
Remove, 2-17
Battery
Charge, 2-11 P
Insert, 2-15
Installation, 2-21 Package contents, 2-2
Level indicator, 2-14 Presets, 3-6
Remove, 2-15
Specifications, 2-16 R
Black and white imaging, 3-6
Regulatory Requirements, i-1
C
S
Cleaning, 6-4
Color aliasing, 3-8 Safety
Color imaging, 3-7 Acoustic output, 7-16
Configuration, 5-1 Electrical hazard, 7-7
Contraindication, 1-3 Electromagnetic Compatibility, 7-9
Equipment safety, 7-7
D Explosion hazard, 7-7
Mechanical hazard, 7-6
Delete Pacemaker hazard, 7-8
Examination, 3-14 Patient safety, 7-5
File, 3-14 Personnel safety, 7-7
Disinfection, 6-4 Probe temperature, 7-20
Switching on/off, 3-2
E System description
Control unit, 2-5
Examination folder, 3-5 Display, 2-6
G T
Gel, 3-3 Troubleshooting, 6-9
I V
Indication for use, 1-3 Vscan Gateway
Information Computer requirements, 4-4
Requesting, 1-7 Connection to Vscan, 4-12
Inspection, 6-3 Installation, 4-5
Overview, 4-14
L Setup screen, 4-20
Labels, 7-21
Vscan – User Manual Index-1

GM092102 05
Index-2 Vscan – User Manual
GM092102 05
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GE Healthcare

This product complies with regulatory requirements of the following European

93/42/EEC Medical Devices Directive (MDD)

EN55011 Emitted noise according to Class B requirements

IEC60601-1 Medical Electrical Equipment, Part 1; General Requirements

IEC60601-2-37 Medical electrical equipment - Part 2-37. Particular

IEC1157 / EN61157 Requirements for the declaration of the acoustic output of

IEC60601-1-2 Medical Electrical Equipment - part 1-2. Collateral standard:

IEC60601-1-4 Medical Electrical Equipment - part 1-4. Collateral standard:

IEC60601-1-6 Medical Electrical Equipment - part 1-6. Collateral standard:

NEMA/AIUM UD-3 Standard for real-time display of thermal and mechanical

ISO10993-1 Biological evaluation of medical devices

Vscan – User Manual i-1

i-2 Vscan – User Manual

Normal mode Single fault condition

Patient leakage current <100 microA <500 microA

Environmental requirements for the unit

Operational 10–40 °C 30–80% 700–1060 hPa

Non operational -20–70 °C 30–90% 700–1060 hPa

NOTE: Avoid exposing the unit to saline moisture. In case of exposure

Vscan – User Manual i-3

Conformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-1

Vscan – User Manual i-5

i-6 Vscan – User Manual

Vscan – User Manual i-7

‘General description’ on page 1-2

‘Warnings’ on page 1-4

‘Conventions used in this manual’ on page 1-6

‘Contact Information’ on page 1-7

Vscan – User Manual 1-1

Vscan is a battery operated pocket-sized general purpose

1-2 Vscan – User Manual

Indication for use

CAUTION For USA only:

Vscan – User Manual 1-3

To prevent damage of the equipment or injury to yourself or

WARNING • Vscan is a precision instrument. Handle Vscan and its

1-4 Vscan – User Manual

WARNING • Do not short-circuit the battery terminal with metallic

Vscan – User Manual 1-5

Conventions used in this manual

Buttons and other controls on the Control panel or on the

DANGER Indicates that a specific hazard exists that, given inappropriate

WARNING Indicates that a specific hazard exists that, given inappropriate

CAUTION Indicates that a potential hazard may exist that, given

1-6 Vscan – User Manual

Contacting GE Healthcare Ultrasound

GE Healthcare TEL: (1) 800-437-1171

Please contact your local Applications or Sales Representative.

For service in the United States, call GE CARES

Vscan – User Manual 1-7

Accessories Catalog Requests

To request the latest GE Accessories catalog or equipment

To place an order, order supplies or ask an accessory-related

Global ultrasound support center phone numbers

Region Telephone Location

United States1 800-437-1171 Milwaukee

Canada 800-668-0732 Moncton

Mexico 0800 9043400 Sao Paulo